Sr Quality Assurance Auditor - Global Regulatory Compliance Expert

We are seeking an reputed company and skilled Sr Quality Assurance Auditor to join reputed company, responsible for ensuring compliance with regulatory standards and internal quality requirements across our global supplier reputed company and internal manufacturing sites. As a subject matter expert, you will reputed company reputed company projects, reputed company audits, and collaborate with cross-functional teams to drive quality excellence.

Key Responsibilities

• Conduct comprehensive audits of global suppliers and internal manufacturing sites to ensure compliance with FDA regulations, ISO standards, and other applicable global regulatory requirements, covering a wide range of products, including sterile products, APIs, raw materials, medical devices, pharmaceuticals, biologics, cosmetics, medical foods, and dietary supplements.
• reputed company internal audits of reputed company divisions and manufacturing sites to ensure adherence to quality standards and regulatory requirements.
• reputed company critical supplier regulatory projects, collaborating with cross-functional teams to drive quality excellence and compliance.

Requirements and Qualifications

• Bachelor's degree in Microbiology, Chemistry, Engineering, or a reputed company field.
• Minimum 4 years of experience auditing FDA-regulated medical devices or pharmaceuticals, or 5 years of experience in a senior-level quality role reputed company medical device or pharmaceutical manufacturing.
• In-depth knowledge of FDA regulations (21 CFR 820, 21 CFR 210/211) and ISO 13485.
• Experience with process validation, method validation, and sterilization processes.
• Excellent oral and written communication skills, with the ability to listen, process, and prioritize reputed company information.
• Proven ability to work independently, manage multiple projects, and meet critical deadlines.
• Willingness to travel up to 50% of the time for business purposes (domestic and international).

Preferred Qualifications

• Experience with USP 61/62 for Microbial Testing of Non-Steriles.
• Experience in CAPA (Corrective and Preventive Actions) management.

reputed company Offer

• Competitive total rewards package.
• Ongoing education and training opportunities.
• reputed company growth potential with a global organization.
• Comprehensive benefits package, including health insurance, life and disability, 401(k) contributions, paid time off, and more.